ERIVEDGE Drug Patent Profile

When do Erivedge patents expire, and when can generic versions of Erivedge launch?

Erivedge is a drug marketed by Genentech and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-four patent family members in twenty-four countries.

The generic ingredient in ERIVEDGE is vismodegib. One supplier is listed for this compound. Additional details are available on the vismodegib profile page.

DrugPatentWatch^® Generic Entry Outlook for Erivedge

Erivedge was eligible for patent challenges on January 30, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 11, 2028. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for ERIVEDGE

International Patents:	54
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	46
Patent Applications:	4,536
Drug Prices:	Drug price information for ERIVEDGE
What excipients (inactive ingredients) are in ERIVEDGE?	ERIVEDGE excipients list
DailyMed Link:	ERIVEDGE at DailyMed

See drug prices for ERIVEDGE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ERIVEDGE

Constraining patent/regulatory exclusivity:

7,888,364

NDA:

203388

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ERIVEDGE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Genentech, Inc.	Early Phase 1
H. Lee Moffitt Cancer Center and Research Institute	Early Phase 1
Ronald Buckanovich	Phase 2

See all ERIVEDGE clinical trials

Pharmacology for ERIVEDGE

Drug Class	Hedgehog Pathway Inhibitor
Mechanism of Action	Smoothened Receptor Antagonists

Paragraph IV (Patent) Challenges for ERIVEDGE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ERIVEDGE	Capsules	vismodegib	150 mg	203388	1	2025-03-27

US Patents and Regulatory Information for ERIVEDGE

ERIVEDGE is protected by two US patents.

This potential generic entry date is based on patent 7,888,364.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012		RX	Yes	Yes	9,278,961
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012		RX	Yes	Yes	7,888,364		Y	Y

Expired US Patents for ERIVEDGE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genentech	ERIVEDGE	vismodegib	CAPSULE;ORAL	203388-001	Jan 30, 2012	9,790,183

EU/EMA Drug Approvals for ERIVEDGE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Roche Registration GmbH	Erivedge	vismodegib	EMEA/H/C/002602Erivedge is indicated for the treatment of adult patients with:- symptomatic metastatic basal cell carcinoma- locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy	Authorised	no	no	no	2013-07-12	2013-04-26

International Patents for ERIVEDGE

See the table below for patents covering ERIVEDGE around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20190072678	헤지호그 신호전달에 대한 피리딜 억제제 (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING)
Brazil	PI0514841	inibidores de piridila da sinalização de hedgehog, processo de preparação dos mesmos e composição compreendendo os referidos inibidores
Eurasian Patent Organization	201890903	СОЕДИНЕНИЯ ПИРИДИЛОВЫХ ИНГИБИТОРОВ ПЕРЕДАЧИ СИГНАЛОВ БЕЛКОМ HEDGEHOG, СПОСОБ ИХ ПОЛУЧЕНИЯ, КОМПОЗИЦИЯ И СПОСОБЫ ЛЕЧЕНИЯ РАКА И ИНГИБИРОВАНИЙ АНГИОГЕНЕЗА И СИГНАЛЬНОГО ПУТИ HEDGEHOG В КЛЕТКАХ НА ИХ ОСНОВЕ
Cyprus	2013042
South Korea	20160058972	헤지호그 신호전달에 대한 피리딜 억제제 (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING)
Mexico	2007002584	INHIBIDORES DE PIRIDILO DE SENALIZACION DE HEDGEHOG. (PYRIDYL INHIBITORS OF HEDGEHOG SIGNALLING.)

Supplementary Protection Certificates for ERIVEDGE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1789390	2014/002	Ireland		PRODUCT NAME: ERIVEDGE-VISMODEGIB OR A SALT OR SOLVATE THEREOF; NAT REGISTRATION NO/DATE: EU/1/13/848 20130712; FIRST REGISTRATION NO/DATE: 62497 01 20130530
1789390	2013C/071	Belgium		PRODUCT NAME: VISMODEGIB; AUTHORISATION NUMBER AND DATE: EU/1/13/84/001 20130715
1789390	C 2013 038	Romania		PRODUCT NAME: VISMODEGIB SI SARURILE SI SOLVATIIACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/848; DATE OF NATIONAL AUTHORISATION: 20130712; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): CH 62497 01; DATE OF FIRST AUTHORISATION IN EEA: 20130530
1789390	SPC/GB13/060	United Kingdom		PRODUCT NAME: VISMODEGIB OPTIONALLY IN THE FORM OF A SALT OR SOLVATE; REGISTERED: CH IKS-NO.62497 20130530; UK EU/1/13/848-EMEA/H/C 20130712
1789390	CA 2013 00050	Denmark		PRODUCT NAME: VISMODEGIB; NAT. REG. NO/DATE: EU71/13/848 20130712; FIRST REG. NO/DATE: CH 62497 20130530
1789390	132013902210830	Italy		PRODUCT NAME: VISMODEGIB(ERIVEDGE); AUTHORISATION NUMBER(S) AND DATE(S): 62497, 20130530;EU/1/13/848, 20130712

ERIVEDGE (vismodegib): Market dynamics and financial trajectory

Last updated: April 23, 2026

What drives ERIVEDGE’s market dynamics?

ERIVEDGE is vismodegib, an oral hedgehog pathway inhibitor. Its market position has been shaped by (1) clinical label scope that is narrower than broader oncology peers, (2) competition within hedgehog pathway biology and by sequencing standards of care, (3) pricing and reimbursement friction typical for targeted oncology drugs, and (4) patent and lifecycle risk as the hedgehog inhibitor class matures.

Core commercial constraints

• Indication scope is disease- and stage-specific. ERIVEDGE is used in advanced basal cell carcinoma settings and has more limited transplantability of demand versus drugs that span multiple tumor types.
• Treatment duration is not fixed. Demand is influenced by durability of response, tolerance, and discontinuation patterns common to hedgehog inhibition.
• Class competition and line-of-therapy effects. Substitution can occur when alternative systemic options improve outcomes or reduce adverse-event burden, which shifts patients away from hedgehog inhibitors.
• Reimbursement and access. For oncology drugs with higher per-patient costs, net sales depend on payer coverage policies, formulary placement, and patient assistance structures.

Demand sensitivity signals seen in the class

Hedgehog inhibitors show demand that tracks:

• New patient starts (diagnosis and referral patterns)
• Continuation rates (tolerability and response durability)
• Switching/line changes when competing therapies become more preferred in a given setting

This demand structure makes revenues more sensitive to changes in clinical practice guidelines, sequencing, and tolerability improvements.

---

How has ERIVEDGE’s financial trajectory moved?

The financial trajectory for ERIVEDGE has been characterized by revenue pressure over time as the product matures, competition increases, and pricing and access normalize after launch. From a market-dynamics standpoint, the key question is whether new demand sources offset loss of patients due to switching and reduced treatment starts.

Revenue build vs. erosion: what matters

A workable way to assess ERIVEDGE’s trajectory is to separate:

• Net new demand drivers
  • Higher diagnosis rates
  • Expanded utilization within labeled settings
  • Geographic growth through payer access improvements
• Erosion drivers
  • Patient switching to alternative systemic regimens
  • Lower initiation rates as physicians move to newer agents
  • Net price pressure from payer contracting

Commercial profile by lifecycle stage

• Early growth (launch years): Revenue was driven by first-wave adoption in advanced basal cell carcinoma and increased awareness among dermatology and oncology referral networks.
• Maturation: Growth typically transitions to plateau as the addressable pool saturates and as competitive substitutions increase.
• Later-stage pressure: Revenue becomes more dependent on maintenance of treatment starts and continuation, which are harder to sustain when competing options become preferred and tolerability barriers lead to discontinuation.

Financial trajectory implication for investors

For hedgehog inhibitor products like ERIVEDGE, the financial trend tends to follow clinical practice rather than purely market expansion. Once a product is established, sustaining revenue depends on:

• Maintaining payer coverage and net pricing
• Retaining patients through tolerability management
• Protecting line-of-therapy position versus newer systemic options

---

What do label and biology mean for revenue durability?

ERIVEDGE’s commercial durability is constrained by the hedgehog pathway biology and the real-world treatment experience.

Real-world utilization drivers

• Patient selection: Advances in diagnostic and treatment stratification affect who receives hedgehog inhibition.
• Tolerance and adherence: Adverse events and discontinuation can reduce average treatment duration and patient retention.
• Response durability: Financial outcomes depend on how long patients remain on therapy and how often they progress.

Lifecycle risk

• Patent and exclusivity timelines shape the speed and magnitude of revenue erosion.
• Lifecycle modifications depend on new formulations or new clinical evidence that can support expanded or refined use.

---

How does competition shape net sales?

Competition hits ERIVEDGE through two primary channels: replacement and sequencing.

Replacement

• Patients and physicians can move to alternative systemic therapies in advanced basal cell carcinoma when efficacy, safety, convenience, or payer preference shift.

Sequencing

• Even if hedgehog inhibitors remain an option, changes in sequencing affect initiation rates. A product can lose revenue without losing eligibility, simply by being moved to a later line.

Commercial outcome

When replacement and sequencing both intensify, revenues tend to decline faster because demand is not only shrinking but also shifting away from early initiation.

---

What is the practical “market dynamics to money” linkage for ERIVEDGE?

For business planning, ERIVEDGE’s financial model is driven by three levers:

1. Patient starts in labeled settings
   • referral and clinical guideline adoption
2. Average treatment duration
   • tolerability management and response durability
3. Net price
   • payer contracting, rebates, and access policies

When the market changes, it usually impacts one or more of these levers. ERIVEDGE’s trajectory has followed the typical pattern for mature oncology targeted therapies: a gradual shift from expansion to erosion as substitution and sequencing pressure build.

---

Key Takeaways

• ERIVEDGE’s market dynamics are constrained by stage-specific label scope, real-world tolerability and adherence, and the hedgehog inhibitor class’s sensitivity to sequencing shifts.
• The financial trajectory reflects lifecycle maturation: revenues face sustained pressure as competition and line-of-therapy preferences reduce initiation and continuation.
• Net sales performance is best understood through three levers: patient starts, average treatment duration, and net price.
• For decision-making, the dominant risks to forward revenue are payer contracting, switching behavior, and loss of early-line positioning as competing systemic options gain share.

---

FAQs

1) Is ERIVEDGE mainly driven by new patient starts or by continuation?

Continuation is a major contributor, but starts dominate revenue sensitivity when sequencing changes reduce initiation. ERIVEDGE’s revenue is therefore sensitive to both.

2) What market events most affect ERIVEDGE revenues?

Changes in clinical practice that alter sequencing, payer formulary decisions that affect net price and access, and new competing therapies that shift physician preference.

3) Does ERIVEDGE have broad oncology cross-use?

No. Its commercial footprint is narrower than multi-tumor oncology agents because its use is tied to advanced basal cell carcinoma settings and the hedgehog pathway biology.

4) What is the main mechanism by which competition reduces ERIVEDGE sales?

Competition reduces revenue by both replacement of patients and sequencing effects that lower initiation rates.

5) What should be monitored for forward outlook?

Patient start volume in labeled indications, treatment persistence metrics, net pricing trends, and any label-supporting evidence that could change physician behavior.

---

References

[1] FDA. “ERIVEDGE (vismodegib) label.” U.S. Food and Drug Administration.
[2] National Cancer Institute. “Basal Cell Carcinoma Treatment (PDQ) and systemic therapy context.” National Institutes of Health.
[3] Drugs.com. “Erivedge (vismodegib) information and prescribing details.” Drugs.com.
[4] NCCN Clinical Practice Guidelines in Oncology. “Basal Cell Skin Cancer.” National Comprehensive Cancer Network.